As an industrial field closely related to public health and life safety, medical instruments cover a wide range, including low-value consumables such as tongue depressors and gauze, as well as high-tech and high-priced equipment such as multi-row CT, PET-CT, superconducting magnetic vibrator and proton accelerator. At present, China's conventional medical devices have basically achieved independent production, and high-end medical devices have also been involved, but the situation of low-tech products with low technical content and low technical level has not changed. By the end of 20 13, there were nearly16,000 medical device manufacturers in China, of which the third category medical device manufacturers accounted for 17%, the second category medical device manufacturers accounted for 54%, and the first category medical device manufacturers accounted for 29%. It can be seen that in China's medical device industry, there are relatively few enterprises producing high-tech three types of medical devices, and the innovation ability needs to be improved urgently.
The newly revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as "Regulations") will be implemented on June 1 2065438. The general provisions of the Regulations clearly state that the state encourages the research and innovation of medical devices, promotes the popularization and application of new technologies of medical devices, and promotes the development of medical device industry. The "Regulations" designed a series of specific systems from the perspectives of optimizing review and approval, reducing the burden on enterprises and encouraging innovation, which provided a strong legal basis and policy basis for promoting the development of the medical device industry and encouraging enterprises to become bigger and stronger.
Under the current mode of "production license first, then product registration", after obtaining the production license of medical devices, manufacturers should also obtain the product registration certificate before they can produce and operate medical devices.
The newly revised regulations further simplify and decentralize the examination and approval of medical device production and operation, and implement classified management of production and operation activities according to the risk degree of medical devices.
The regulations also pay special attention to the positive role of industry organizations in ensuring the safety and effectiveness of medical devices and promoting the development of the medical device industry, requiring medical device industry organizations to strengthen industry self-discipline, promote the construction of credit system, and guide enterprises to be honest and trustworthy; It is also clearly stipulated that the food and drug supervision and administration department of the State Council shall openly solicit opinions and listen to the opinions of experts, medical device manufacturers and users, consumers and relevant organizations when formulating, adjusting and amending the catalogue stipulated in the Regulations and the norms related to the supervision and administration of medical devices.
China's "Twelfth Five-Year Plan for National Economic and Social Development" clearly puts forward that it is necessary to strengthen technological transformation of enterprises, accelerate the application of new technologies, new materials, new processes and new equipment to upgrade traditional industries, improve market competitiveness, encourage enterprises to enhance new product development capabilities, improve product technical content and added value, and accelerate product upgrading. With the progress of science and technology and the improvement of public living standards, new medical devices with new functions, superior performance, safer and more effective diagnosis and treatment are constantly emerging, and various new scientific and technological means such as computer technology, microelectronics technology, finishing technology and intelligent technology are applied to the design and development of medical devices. Affected by natural and social factors, China's population continues to grow, and the aging is becoming increasingly prominent; At the same time, in order to promote the integration of urban and rural development, the state vigorously promotes urbanization, which provides huge market demand for medical device products and broad prospects for the development of medical device industry. The birth, development and application of new technologies are inseparable from the support and guarantee of the system. At this time, the "Regulations" came out, in which the provisions on reducing the pressure on enterprises and encouraging innovation provided a superior legal basis for the regulatory authorities to formulate specific measures and practical steps to support medical device innovation, which will surely play a powerful guiding and promoting role in the upgrading of the medical device industry. Recently, on the basis of classified management, the Regulations on the Supervision and Administration of Medical Devices revised and issued by the State Council highlighted the scientific nature of risk management, rationally designed and improved the review and approval mechanism, and further standardized the filing permit system for medical devices before listing, which reflected the spirit of "establishing the strictest supervision system covering the whole process" proposed by the Third Plenary Session of the 18th CPC Central Committee.
First, the scientific design of medical device classification management system
Medical devices are divided into one, two and three categories according to their risks, and the third category is the product with the highest risk. The Regulation runs through the concept of medical device risk management, and the classification requirements for medical devices are more detailed, rigorous, clear and more operable.
Second, further clarify the division of powers between the central and local governments.
Medical device registration means that the food and drug supervision and management department systematically evaluates the safety, effectiveness and quality controllability of medical devices to be listed according to the application and legal procedures of medical device registration applicants, so as to decide whether to approve their applications.
The State Food and Drug Administration is also responsible for formulating the classification rules and catalogues of medical devices and the catalogues of medical devices exempted from clinical trials; Formulate, adjust and publish the catalogue of disposable medical devices in conjunction with the health and family planning department of the State Council.
Three, strengthen the reform of medical device review and approval system
The "Regulations" are more scientific and reasonable in establishing the examination and approval system for medical devices.
Technical evaluation of medical devices is an important technical support for registration management. At the same time, accelerate the informatization construction of medical device registration management, strengthen the disclosure of medical device registration information, encourage and support the participation of all sectors of society under the premise of giving play to the leading role of the government, give full play to the role of social organizations and medical device industry associations, participate in medical device registration management, and expand regulatory resources. The newly revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as "Regulations") will be implemented on June 1 2065438.
First of all, the implementation of medical device adverse event monitoring system is conducive to early warning and prevention of product risks. With the development of China's economy and society and the improvement of people's living standards and health awareness, the public's requirements for the safety of medical devices are getting higher and higher. Medical device manufacturers, operators and users need to strengthen the monitoring of product safety and effectiveness. Food and drug regulatory authorities need to continuously improve the ability of monitoring and evaluating adverse events of medical devices, extract risk signals by collecting and evaluating adverse event reports, timely discover and control the risks of medical device products after listing, and eliminate hidden dangers. Strengthening the monitoring of medical device adverse events can not only provide regulatory basis for food and drug regulatory authorities, but also take necessary measures to reduce or avoid the recurrence of similar adverse events, reduce the risk of patients, medical personnel and other personnel using medical devices, and ensure the safety of the broad masses of people using medical devices; It can also effectively promote the improvement and upgrading of products by enterprises, promote the research and development of new products, and help promote the healthy development of China's medical device industry.
Second, the re-evaluation of medical devices is conducive to controlling the risks of medical device products after listing. Re-evaluation of medical devices is an important part of post-marketing supervision of medical devices and an important link to ensure the safety of public use of devices. Re-evaluation of high-risk products after listing is actually a process of re-evaluating the safety and effectiveness of such products.
Third, the establishment of a medical device recall system is conducive to ensuring the safety of public equipment. The recall system is established for defective products that have entered the market. Because defective products often have the characteristics of batch, when these products are put on the market, if they are not intervened, their potential harm is great, which may cause damage to consumers' life, property safety or environment, and bring security risks to society and the public. The safety and effectiveness of medical devices are directly related to people's health and life safety. The newly revised Regulation on the Supervision and Administration of Medical Devices has been promulgated and will be implemented on June 20 1 year 14, which is a major event in the modernization of medical device supervision in China.
First, improve the risk management ability of medical devices.
Supervision modernization is an important part of the modernization of state governance. Risk management is the only way to modernize supervision. The new "Regulations" improve the risk management ability of medical devices from three aspects: source governance, system governance and legal governance.
(1) Source governance, coordinating the relationship between supervision and development.
(2) Systematic governance and rational allocation of horizontal and vertical regulatory power. To deal with systemic and overall risks, we must rationally allocate horizontal and vertical regulatory power. The second is to scientifically allocate regulatory resources vertically. The division of powers between central and local governments mainly depends on the balance between the external costs of spillover and the internal benefits of localization. The new "Regulations" give full play to the advantages of local authorities in grasping actual information on the basis of emphasizing the unity of authoritative regulatory agencies by adjusting the authority of examination and approval and filing. In the registration process, the first-class medical devices were changed from the approval of the Municipal Bureau to the filing, and the second-class and third-class medical devices were retained for approval by the Provincial Bureau and the General Administration respectively. In the production process, the first-class medical device manufacturers shall file with the provincial bureau, the second and third-class medical devices shall be examined and approved by the provincial bureau, the first-class medical device manufacturers shall file with the local bureau, and the second and third-class medical devices shall be examined and approved by the provincial bureau. Business links, by the medical device business enterprises to the provincial bureau for the record, two or three categories by the provincial bureau for examination and approval, one category without filing or approval, two categories by the municipal bureau for the record, three categories by the municipal bureau for examination and approval.
(3) Ruling by law and establishing the strictest supervision system. Rule of law is the core of supervision modernization. We must strictly abide by laws and standards, ensure the safety and effectiveness of medical devices with the strictest supervision, the most severe punishment and the most serious accountability, and all institutions' qualifications will be revoked and included in the "blacklist", and applications for qualification recognition will not be accepted within 10 years; The person directly responsible shall be dismissed and shall not be engaged in medical device inspection for 10 years.
Second, decentralization should not forget the combination of "liberalization" and "management"
Government and market are two basic elements to stimulate economic vitality. To build an "upgraded version" of China's economy requires a new breakthrough in product quality.
(A) improve the scientific classification management system. There are many kinds of medical devices, with large span and complex formats, and the risks are different from nuclear magnetic vibration instrument to tongue depressor.
(2) Appropriately reduce the prior administrative examination and approval. Reduce the government's improper intervention in the operation of the market, put what the market and society can do as far as possible out and in place, and stimulate the vitality of various market players. The current laws and regulations stipulate 16 items of administrative license. The new regulations not only do not add new licenses, but also reduce seven licenses in combination with the previous administrative license clearance.
(three) efforts to strengthen the management of post supervision. The more we reduce the prior permission, the more we should keep up with the post-event supervision and effectively manage the government's affairs.
Third, innovate the social governance model.
(1) Let the producers and operators truly become the first person responsible for the safety of medical devices. Under the premise of giving full play to the leading role of the government, the new regulations emphasize the main responsibility of enterprises.
(two) to mobilize the enthusiasm of social supervision. 20 13 "institutional reform and functional transformation plan of the State Council" emphasizes giving full play to the role of market mechanism, industry self-discipline and social supervision in food and drug supervision. The new "Regulations" stipulate that medical device industry organizations should strengthen industry self-discipline and guide enterprises to be honest and trustworthy; Add a complaint reporting system to reward the verified reports and stimulate the enthusiasm of the whole society to participate in the governance of * * *.
(3) Innovation of supervision mode focusing on informatization. Informatization is an important tool for modern regulatory agencies, which is usually more efficient than hard control. The new "Regulations" stipulate that a unified national information platform for medical device supervision should be established, and the food and drug supervision departments should timely publish information such as medical device licensing, filing, spot check and inspection, and investigation of illegal acts through the platform. The change of regulatory information from government exclusive to open and transparent can not only force enterprises to cherish their reputation, but also improve the quality management level; It can also help consumers identify the advantages and disadvantages of products and promote healthy competition in the market. More importantly, the innovation of supervision mode focusing on informatization represents the development direction of supervision in the future.